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A Study of the Efficacy, Safety, and Tolerability of KAN-101 in Participants With Celiac Disease
EU CTIS ID: 2023-507240-37-00
What this study is testing
Assess the ability of KAN-101 to attenuate gluten challenge (GC)-induced changes in duodenal histology as measured by changes in villus-height:crypt depth (Vh:Cd) ratio after a 2-week GC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 to 70 years inclusive.
- Previously documented diagnosis of CeD based on positive serology (eg, tissue transglutaminase IgA antibody and/or DGP IgG) AND intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
- HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening.
- Have followed a gluten-free diet for ≥12 months immediately prior to study entry (self-reported).
- Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher.
You likely can't join if
- Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or symptoms with substantial villous atrophy (eg, documented Marsh score 3c in source data) despite strict adherence to a GFD for at least 12 months in absence of other disorders.
- Previous treatment with tolerance-inducing therapies for CeD.
- Selective IgA deficiency.
- Positive for HLA-DQ8 genotype (DQA1*03, DQB1*0302) even if DQ2.5 is also present.
- Known wheat allergy.
- Diagnosis of type-I diabetes.
See the full eligibility criteria
- Adults aged 18 to 70 years inclusive.
- Previously documented diagnosis of CeD based on positive serology (eg, tissue transglutaminase IgA antibody and/or DGP IgG) AND intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
- HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening.
- Have followed a gluten-free diet for ≥12 months immediately prior to study entry (self-reported).
- Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher.
- Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or symptoms with substantial villous atrophy (eg, documented Marsh score 3c in source data) despite strict adherence to a GFD for at least 12 months in absence of other disorders.
- Previous treatment with tolerance-inducing therapies for CeD.
- Selective IgA deficiency.
- Positive for HLA-DQ8 genotype (DQA1*03, DQB1*0302) even if DQ2.5 is also present.
- Known wheat allergy.
- Diagnosis of type-I diabetes.
- History of dermatitis herpetiformis.
- Pregnant or breastfeeding.
- Known history of severe hypersensitivity reactions or anaphylaxis to gluten.
- Active gastrointestinal disease other than CeD (eg, inflammatory bowel disease, any forms of colitis except well-controlled microscopic colitis, uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active GI infections).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.